A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in matsudo city, japan.Livanova initiated an investigation.This report was due on december 02, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on (b)(6) 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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